Circulating Tumor CellNCT04083547
Circulating Tumour Cells in Patients With Peritoneal Metastases
An observational study of Circulating Tumor Cell and Peritoneal Metastases, run by Uppsala University at 1 site in Sweden.
Trial summary
This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Circulating Tumor Cell, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy
- What is being tested?
- iCellate
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 17 Oct 2017to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients being treated in Uppsala with CRS and HIPEC will be asked to join the study.
Who may be able to join
- Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cirkulerande Tumörceller Hos Patienter Med Bukhinnespridda tumörer
This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum.
Read the detailed description
CTCs har extracted by way of a new method at baseline, during surgery, and postoperatively. The occurence of such CTCs will be investigated for prognostic evaluation. Patients will be follow-up by Clinical routine. Disease recurrence and overall survival will be the endpoint used.
- Being tested
- iCellate
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCellateDiagnostic test
New method of circulating tumour cell detection and capture.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC group | All patients undergoing HIPEC will asked to join this prospective study. Receives: Diagnostic Test: iCellate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value
Prediction of survival and recurrence according to the occurrence of CTCs.
Measured: 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start17 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083547
- Sponsor's protocol ID
- CTC study
- Status last verified
- Nov 2020
- First submitted
- 5 Sep 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cirkulerande Tumörceller Hos Patienter Med Bukhinnespridda tumörer
- ClinicalTrials.gov ID
- NCT04083547
- Acronym / sponsor ID
- CTC study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum.
Detailed description
CTCs har extracted by way of a new method at baseline, during surgery, and postoperatively. The occurence of such CTCs will be investigated for prognostic evaluation. Patients will be follow-up by Clinical routine. Disease recurrence and overall survival will be the endpoint used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC group | – | Diagnostic Test: iCellateAll patients undergoing HIPEC will asked to join this prospective study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients being treated in Uppsala with CRS and HIPEC will be asked to join the study.
Key inclusion criteria (1 listed)
- Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCellateNew method of circulating tumour cell detection and capture. | Diagnostic test | HIPEC group |
Primary outcome
Prognostic value
Time frame: 2 year.
Prediction of survival and recurrence according to the occurrence of CTCs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor Cell and Peritoneal Metastases, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value (time frame: 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.